Dover urinary catheter drainage bag occlusion defect nationwide recall
Cardinal Health is recalling Dover urinary catheter trays due to potential blockage of the drainage bag inlet port, which may prevent urine drainage and increase the risk of urinary retention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a functional defect that creates a risk of medical complication (urinary retention). No illnesses or injuries have been reported in the source material. Per the rubric, this qualifies as High severity for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health is recalling Dover Closed Urethral Trays with Vinyl Catheter (14 Fr/Ch, 4.7 mm, 5 mL) that are pre-connected to 1000 mL drainage bags. The recall is due to an occlusion (blockage) of the bubble inlet port on the drainage bag, which may prevent urine from draining into the bag properly.
The affected product code is 3450, distributed nationwide. The recall affects units with the following lot numbers: 2216502264, 2216507864, 2215825864, 2215119164, 2214451964, 2213740964, 2213046464, 2212401364, 2212401264, 2211101164, 2211101264, 2209515164, 2210219664, 2209515264, 2209501064, 2207800564, 2208816364, 2207401264, and 2207401164.
This catheter system is intended for urinary drainage from the bladder. If the bladder is not emptied within a clinically appropriate time due to the drainage blockage, the risk of urinary retention increases. Healthcare facilities and providers using affected units should be aware of this defect.
The recalled product
- Product
- Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
- Manufacturer
- Cardinal Health
- Hazard
- blockage
- urinary-retention
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI-DI: Each 10884521009479 Case 20884521009476 Lot Numbers: 2216502264
- 2216507864
- 2215825864 2215119164
- 2214451964
- 2213740964 2213046464
- 2212401364
- 2212401264 2211101164
- 2211101264
- 2209515164 2210219664
- 2209515264
- 2209501064 2207800564
- 2208816364
- 2207401264 2207401164
Distribution
Distributed nationwide across the United States.
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